UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008104
Receipt No. R000009538
Scientific Title Prospective stady of comparison of the syringe pump exchange methods in blood pressure stability between simple methods with step down methods.
Date of disclosure of the study information 2012/06/08
Last modified on 2013/02/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective stady of comparison of the syringe pump exchange methods in blood pressure stability between simple methods with step down methods.
Acronym Prospective stady of comparison of the syringe pump exchange methods in blood pressure stability between simple methods with step down methods.
Scientific Title Prospective stady of comparison of the syringe pump exchange methods in blood pressure stability between simple methods with step down methods.
Scientific Title:Acronym Prospective stady of comparison of the syringe pump exchange methods in blood pressure stability between simple methods with step down methods.
Region
Japan

Condition
Condition The patients after cardiovascular surgery
Classification by specialty
Anesthesiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compare the blood pressure stability in the patients of noradrenaline infusion between simple exchange methods with step down methods.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood pressure change (30min after exchange)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Simple exchange methods
Interventions/Control_2 Step down methods
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients after cardiovascular surgery
Key exclusion criteria High dose noradrenaline infusion (more than 0.2microg/kg/min)
Adrenaline infusion
Cardiac support with IABP and/or PCPS
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kota Kamizato
Organization University of the ryukyus
Division name Department of anesthesiology
Zip code
Address 207Uehara Nishihara-cho OKINAWA,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of the ryukyus
Division name Department of anesthesiology
Zip code
Address 207Uehara Nishihara-cho OKINAWA,Japan
TEL
Homepage URL
Email

Sponsor
Institute University of the ryukyus
Institute
Department

Funding Source
Organization University of the ryukyus
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 05 Day
Last modified on
2013 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009538

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.